Data Regulatory Specialist

4 days ago

Kozhikode, Kerala, India beBeeRegulatory Full time ₹ 15,00,000 - ₹ 25,00,000

About the Opportunity

We are seeking a detail-oriented professional to join our Regulatory Intelligence team in a dynamic role that blends regulatory expertise with data management and process improvement.

This challenging position involves monitoring and analyzing the global regulatory landscape within the life sciences industry, requiring strong organizational and communication skills.

Responsibilities:

  • Monitor, acquire, track and categorize information related to the evolving global regulatory landscape within the life sciences industry.
  • Maintain a thorough awareness of all current and relevant regulations, guidelines, policies, procedures, and practices.
  • Utilize a strong understanding of GXP to proactively identify, categorize, and analyze regulations, rules, and guidance document changes.
  • Collaborate with teams to identify and assess emerging trends in the pharmaceutical and medtech regulatory environments.
  • Conduct data quality checks to ensure the accuracy, completeness, and integrity of regulatory data.
  • Monitor and report on key performance indicator (KPI) metrics related to regulatory activities.
  • Ensure that all data acquisition and processing processes are clearly defined and consistently followed.

Qualifications:

  • A minimum of 2 years of experience in the pharmaceutical or medical device industries, with a focus on regulatory affairs or quality assurance.
  • A Bachelor's degree in a relevant field is required; a Master's degree is preferred.

Required Skills:

  • Effective Communication: Develop clear, concise communications across multiple platforms, ensuring accurate and timely sharing of regulatory intelligence insights and updates with teams and stakeholders.
  • Decision Quality: Analyze and evaluate regulatory data, rules, and guidance document changes to make informed decisions that drive forward the organization's regulatory intelligence activities.
  • Project Management: Organize and prioritize multiple time-sensitive projects related to monitoring, tracking, and categorizing global regulatory information, maintaining a high level of attention to detail to ensure data accuracy and relevance.
  • Nimble Learning: Stay updated on the evolving global regulatory landscape, using new insights to improve regulatory intelligence processes and outcomes.
  • Tech Savvy: Leverage digital tools and technology solutions to monitor regulatory changes, ensuring data accuracy and integrity.

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